SARS-CoV-2

In 2020, researchers witnessed the emergence of post-acute sequelae of SARS-CoV-2 (PASC) — more commonly referred to as “long COVID.” Now, the notion of “long vax,” persistent and varying symptoms following COVID-19 vaccination, has come into focus, as Science has noted. This phenomenon, while not as widespread as long COVID, has concerned some in the…

Researchers at Tel Aviv University have identified two monoclonal antibodies that are broadly effective against SARS-CoV-2 variants. The researchers investigated the activity of nine anti-SARS-CoV-2 monoclonal antibodies (mAbs) against several variants of concern, including alpha, beta, gamma, delta and omicron. The scientists at the Tel Aviv University’s Sackler Faculty of Medicine suspect that the antibodies…

FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted today to recommend the use of variant-specific boosters. Out of 21 voting members, 19 supported the use of a SARS-CoV-2 omicron component for COVID-19 booster vaccines. “I want to be clear that this doesn’t mean that we are saying that there will be boosters recommended for everyone…

GSK plc (LSE/NYSE:GSK) and Sanofi (EPA:SAN) have announced that their adjuvanted bivalent vaccine candidate had 72% efficacy against omicron in adults in stage 2 of a Phase 3 study. For those with SARS-CoV-2 seropositivity, the vaccine was 93.2% effective against omicron. The vaccine is based on the original D614 virus and the beta (B.1.351) strain.…

A COVID-19 vaccine from the French vaccine company Valneva SE (Nasdaq:VALN; Euronext Paris:VLA) has become the sixth to win regulatory approval in the United Kingdom. Valneva also anticipated that it would receive the regulatory nod from the European Medicines Agency (EMA) for its COVID-19 vaccine in April. Officials at the ​​Medicines and Healthcare products Regulatory Agency (MHRA)…

The oncology biopharma Veru Inc. (Nasdaq:VERU) revealed positive efficacy and safety data from an interim analysis of a Phase 3 trial testing oral sabizabulin 9 mg against placebo. The trial enrolled 210 hospitalized COVID-19 patients with an elevated risk of acute respiratory distress syndrome (ARDS). The interim analysis focused on data collected from 150 of…

A controversial SARS-CoV-2 challenge study involving 36 volunteers found that 47% of individuals did not develop COVID-19. The volunteers were unvaccinated and had no evidence of prior infection with SARS-CoV-2. The study, whose results were recently published in a pre-print, could potentially point to new vaccine targets or inspire future COVID-19 drug research. “This study has…

Pardes Biosciences (NSDQ:PRDS) said its PBI-0451 twice-daily COVID-19 pill candidate had favorable tolerability and good oral bioavailability, based on interim data from an ongoing Phase 1 trial. The company also said the drug candidate lacked clinically significant drug-drug interactions. “We’re very encouraged by the safety profile and bioavailability profile we’re seeing to date,” Brian Kearney,…

An NIH authored preprint concluded that an omicron-specific version of Moderna’s (NSDQ:MRNA) vaccine might not offer improved immunity or protection compared to the company’s current mRNA-1273 vaccine. In a small study involving macaques, NIH researchers tested neutralizing antibody levels and B cell expansion in primates receiving mRNA-1273 and mRNA-1273.529, the updated vaccine.  The study involved a total…

Sorrento Therapeutics (NSDQ:SRNE) revealed that its late-stage preclinical main protease inhibitor STI-1558 inhibited omicron virus entry and replication in cell-based assays. Prior research indicates that STI-1558 offers broad-spectrum activity against SARS-CoV-2. STI-1558 is distinct from Pfizer’s SARS-CoV-2 drug Paxlovid (nirmatrelvir), which pairs the SARS-CoV-2-3CL protease inhibitor PF-07321332 with ritonavir, which works as a pharmacokinetic enhancer.…

U.S. researchers have found that cannabinoid acids extracted from cannabis sativa prevented infection of human epithelial cells. They conclude cannabinoids may also have the potential to treat COVID-19. Using a pseudovirus expressing the SARS-CoV-2 spike protein, the scientists found that cannabigerolic acid (CBGA) and cannabidiolic acid (CBDA) effectively blocked infection from the alpha (B.1.1.7) and beta…

Bharat Biotech (Hyderabad, India) and its partner Ocugen (NSDQ:OCGN) have announced that their Covaxin (BBV152) COVID-19 vaccine candidate generated a strong neutralizing antibody response to the omicron (B.1.529) and delta (B.1.617.2) variants. The data comes from a study at Emory University involving sera from participants who received three doses of the vaccine with a 28-day…

Adagio Therapeutics (NSDQ:ADGI) saw its share price drop 82% to $6.85 in afternoon trading after releasing data reflecting a reduction in vitro neutralizing activity of ADG20 against the Omicron SARS-CoV-2 variant.  ADG20, the company’s lead product candidate, is a neutralizing monoclonal antibody intended to potentially treat and prevent COVID-19.  In vitro data from authentic and…

GlaxoSmithKline (LON:GSK) and its partner Vir Biotechnology (NSDQ:VIR) have announced that their COVID-19 drug sotrovimab continues to offer protection against the mutations in the spike protein of the Omicron SARS-CoV-2 variant. In March, the two companies received emergency use authorization (EUA) for the drug. The EUA specifically covers the treatment of mild-to-moderate COVID-19 in high-risk adults…

Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) are planning to research their vaccines’ effectiveness against the highly mutated Omicron variant (B.1.1.529), which is behind a surge in infections in Johannesburg, South Africa. If needed, they plan to create new versions of their vaccines. The Omicron variant has more than 30 changes to the SARS-CoV-2 spike protein. “I…

Senator Edward J. Markey (D-Mass.) has sent a letter to the National Institute of Allergy and Infectious Disease (NIAID) asking for a status update regarding ongoing research to develop a universal COVID-19 vaccine. NIAID had awarded $36.3 million to academic institutions to working on coronavirus vaccines that potentially protect against multiple types of coronaviruses. Coronavirus…

One of the first focuses of organ-chip specialist Emulate (Boston) was to reduce the need for animal testing over time. Its technology can simulate tissue-tissue interfaces within organs using human cells. But the potential of the organ chips to yield mechanistic insights for drug discovery and understanding toxicities has become more evident over time.  The…

FDA’s Vaccines and Related Biological Products Advisory Committee has endorsed the Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) COVID-19 vaccine for children 5 to 11. A total of 17 out of 18 members voted that the vaccine’s benefits outweighed the risk in the age group. VRBPAC member Dr. Michael Kurilla, the director of NIH’s Division of Clinical Innovation, abstained from…

Interest in oral antivirals has surged in recent weeks. Merck (NYSE:MRK) announced on October 1 that the investigational antiviral molnupiravir appeared to halve the risk of hospitalization from COVID-19. Roche (SWX:ROG) and Atea (NSDQ:AVIR) are having less luck with the oral, direct-acting antiviral drug candidate AT-527. The two companies announced that the Phase 2 MOONSONG trial…

Antivirals have several advantages over vaccines. They tend to be broadly effective against viral variants and offer faster-acting protection than vaccines. In addition, antivirals are usually simple to transport and don’t require ultra-cold storage. And oral antivirals would have an advantage in terms of the speed of protection they offer. For SARS-CoV-2, antivirals also could…

The oral antiviral molnupiravir from Merck (NYSE:MRK) and Ridgeback Biotherapeutics fared well in a planned interim analysis of the Phase 3 MOVe-OUT trial. If authorized by FDA, the pill would be the first oral antiviral for SARS-CoV-2 in the U.S. To date, all authorized or approved COVID-19 drugs require subcutaneous, intramuscular or intravenous administration. Merck…

Pfizer (NYSE:PFE) has announced the launch of the Phase 2/3 EPIC-PEP study to test its oral antiviral candidate PF-07321332 as a post-exposure prophylaxis against COVID-19. The EPIC-PEP study, whose name is an acronym of “Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis,” will test the efficacy of PF-07321332 with low-dose ritonavir to prevent COVID-19…

Pardes Biosciences, a biopharma upstart based in Carlsbad, California, has announced that the U.S. Patent and Trademark Office has issued a new patent No. 11,124,497. The patent relates to compounds intended to inhibit the main protease (Mpro) of SARS-CoV-2.   “This issued patent is the first from our growing IP portfolio and reflects our commitment to…

The rapid pace of development of COVID-19 vaccines and antibodies has redefined expectations for clinical trials. As SARS-CoV-2 variants such as Delta continue to fuel the epidemic, the industry must continue to ensure testing and clinical trials stay ahead of mutations. To get a clearer sense of what the ramifications of this accelerated development will…

Two months after exiting stealth mode via a SPAC merger, the early-stage biopharma Pardes Biosciences (Palo Alto, California) has launched a first-in-human trial for its investigational COVID-19 pill PBI-0451. The origins of the company stretch back to the early days of the pandemic, said Dr. Uri Lopatin, CEO and co-founder of the company. A visiting…